CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Standard MaskWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug33 Aerosol-reducing Mask Wiki 1.00

Correlated MeSH Terms (7)


Name (Synonyms) Correlation
D009102 Multiple Organ Failure NIH 1.00
D018746 Systemic Inflammatory Response Syndrome NIH 0.58
D058186 Acute Kidney Injury NIH 0.45
D055371 Acute Lung Injury NIH 0.16
D013577 Syndrome NIH 0.15
D012127 Respiratory Distress Syndrome, Newborn NIH 0.15
D012128 Respiratory Distress Syndrome, Adult NIH 0.13

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 Non-invasive Positive Pressure Ventilation Mask to Minimize Mask Leak and Potential Aerosolization Leading to Spread of Virus Such as COVID-19: A Non-inferiority Trial

Patients presenting to the emergency department, or needing hospitalization, for a variety of medical conditions often require non-invasive ventilation (breathing support). For example, for a person with shortness of breath as a complication of COPD (Chronic obstructive pulmonary disease) the gold standard of care requires application of a BiPAP machine. However, in the current environment of COVID-19, the aerosols produced by this machine in a COVID-19 positive patient pose serious potential harms to healthcare providers and other patients. All patients with similar symptoms to COVID-19 need to be treated as positive until definite testing determines otherwise. The best test available for COVID-19 takes up to 4 hours to determine the patients status, which is too long to delay application of a BiPAP. This could lead to either a delay in care or the need for invasive breathing measures (intubation), which requires intense resource utilization, may not be in line with a patient's goals of care, and could cause serious harms (i.e. infection, medication reactions, etc.) in patients who do not need it. The use of a closed-loop BiPAP machine in which no expired air is released into the environment would solve these problems. Building off the failures of a similar approach that was trialed in Italy in response to the COVID-19 crisis, this project will develop and test a novel closed-loop BiPAP system.

NCT04344925 COVID-19 Device: Aerosol-reducing Mask Device: Standard Mask

Primary Outcomes

Description: The primary objective of this study is to assess if the mask device leaks when attached to a patient's face in real-world use. This outcome will be measured by having a researcher assess the physical seal on the patient four times throughout the device's use. The researcher will also screen the non-invasive ventilator machine for indications that the leak alarm has been triggered throughout the participant's engagement in the study. This outcome will be measured by total leak volume litres/minute.

Measure: Total Leak Volume of Non Invasive Ventilation Mask

Time: Baseline to 24 hours

Secondary Outcomes

Description: Metabolic data will include measuring the patients level of consciousness through the 15 point Glasgow coma scale (3-15 points, 3 points= lowest level of consciousness (no response, decompensation of patient), 15= awake, oriented, responding appropriately).

Measure: Glasgow Coma Scale(GCS)

Time: Baseline to 24 hours

Description: Respiratory status will be measured in part by the patients respiratory rate by respirations per minute. Normal respiratory rate is 12-20 respirations per minute.

Measure: Respiratory Rate

Time: Baseline to 24 hours

Description: Patient's condition will be measured by vital signs including heart rate in beats per minute. Normal heart rate is 60-100 beats per minute.

Measure: Heart Rate

Time: Baseline to 24 hours

Description: The patients pH will be measured to monitor patient condition throughout the study. Normal pH 7.35-7.45. Increasing acidosis indicative of worsening hypercapnia.

Measure: Metabolic Data: Blood Gas Measurements

Time: Baseline to 24 hours

Description: The patients HC03 level will be measured in mmol/L to monitor patients condition throughout the study.

Measure: Metabolic Data: Bicarbonate (HC03)

Time: Baseline to 24 hours

Description: The patients PaC02 level will be measured in mmHg to monitor patients condition. throughout the study. Increase in PaC02 levels indicative of worsening hypercapnia.

Measure: Metabolic Data: Partial Pressure of Carbon Dioxide (PaC02)

Time: Baseline to 24 hours

Description: The patients Pa02 level will be measured in mmHg to monitor patients condition throughout the study.

Measure: Metabolic Data: Partial Pressure of Oxygen (Pa02)

Time: Baseline to 24 hours


No related HPO nodes (Using clinical trials)